Single-Center, Randomized, Cohort, Single-Blind, Comparative Clinical Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of RPH-104 in a New 80 mg/mL Dosage Form Following Single Subcutaneous and Intravenous Administration at Doses of 80 mg, 160 mg, and 320 mg in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- The area under the plasma drug concentration-time curve (AUC) of RPH-104 from the moment of administration to infinity after a single injection of RPH-104
研究概览
简要总结
The purpose of this study is to evaluate the safety, immunogenicity and pharmacokinetics of RPH-104 after single intravenous and subcutaneous administration to healthy volunteers at different doses
详细描述
This clinical study is a single-center, simple-blind, randomized, comparative phase I clinical study conducted in 3 parallel cohorts:
In cohort A, a simple blind design is proposed with a single intravenous administration of the study drug at 3 increasing doses (N = 30, 10 volunteers per dose group): 80 mg, 160 mg, 320 mg
In cohort B, a simple blind design is proposed with a single subcutaneous administration of the study drug (80 mg/mL; 320 mg) compared to placebo (N = 20, 10 volunteers per drug and placebo group)
In cohort C, a simple blind design is proposed with a single subcutaneous administration of the study drug in two dosages (40 mg/mL and 80 mg/mL) in one dose (80 mg) to confirm the equivalence of these dosages (N = 80, 40 volunteers in each group)
The study will include the following periods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort A: RPH-104, intravenous administration 80 mg
Subjects received RPH-104 Intravenously once as a 60-minute infusion at a dosage of 40 mg/mL, at a dose of 80 mg. The volume of the infusion solution was 100 ± 8 mL
干预措施: RPH-104 80 mg (Biological)
Cohort A: RPH-104, intravenous administration 160 mg
Subjects received RPH-104 Intravenously once as a 60-minute infusion at a dosage of 40 mg/mL, at a dose of 160 mg. The volume of the infusion solution was 100 ± 8 mL
干预措施: RPH-104 160 mg (Biological)
Cohort A: RPH-104, intravenous administration 320 mg
Subjects received RPH-104 Intravenously once as a 60-minute infusion at a dosage of 40 mg/mL, at a dose of 320 mg. The volume of the infusion solution was 100 ± 8 mL
干预措施: RPH-104 320 mg (Biological)
Cohort B: RPH-104, subcutaneous administration 320 mg
Subjects received a single subcutaneous injection of either RPH-104 at a dosage of 80 mg/mL, at a dose of 320 mg (2 injections of 2 mL), or a placebo (2 injections of 2 mL)
干预措施: RPH-104 320 mg (Biological)
Cohort B: Placebo
Placebo Comparator, Placebo
干预措施: Placebo (Drug)
Cohort C: RPH-104, subcutaneous administration 80 mg (40 mg/mL)
Subjects received a single subcutaneous injection of either RPH-104 at a dosage of 40 mg/mL, at a dose of 80 mg (1 injection of 2 mL)
干预措施: RPH-104 80 mg (Biological)
Cohort C: RPH-104, subcutaneous administration 80 mg (80 mg/mL)
Subjects received a single subcutaneous injection RPH-104 at a dosage of 80 mg/mL, at a dose of 80 mg (1 injection of 1 mL)
干预措施: RPH-104 80 mg (Biological)
结局指标
主要结局
The area under the plasma drug concentration-time curve (AUC) of RPH-104 from the moment of administration to infinity after a single injection of RPH-104
时间窗: Up to day 61 ± 3
The area under the plasma drug concentration-time curve (AUC) of RPH-104 from the moment of administration to infinity after a single injection of RPH-104 (AUC(0-∞))
The maximum concentration of RPH-104 in the blood serum after a single injection of RPH-104
时间窗: Up to day 61 ± 3
The maximum concentration of RPH-104 in the blood serum after a single injection of RPH-104 (Cmax).
Percentage of volunteers (%) with AEs and SAEs
时间窗: Up to day 61 ± 3
Percentage of volunteers (%) with AEs and SAEs
Percentage of volunteers (%) with AEs ≥ Grade 3 according to CTCAE 5.0
时间窗: Up to day 61 ± 3
Percentage of volunteers (%) with AEs ≥ Grade 3 according to CTCAE 5.0
Percentage of volunteers (%) with ADRs and serious ADRs
时间窗: Up to day 61 ± 3
Percentage of volunteers (%) with ADRs and serious ADRs
Percentage of volunteers (%) with ADRs ≥ Grade 3 according to CTCAE 5.0
时间窗: Up to day 61 ± 3
Percentage of volunteers (%) with ADRs ≥ Grade 3 according to CTCAE 5.0
Percentage of volunteers (%), who prematurely discontinued participation in the study due to AE/SAE and ADR/serious ADR
时间窗: Up to day 61 ± 3
Percentage of volunteers (%), who prematurely discontinued participation in the study due to AE/SAE and ADR/serious ADR
Percentage of volunteers (%) with AEs of special interest
时间窗: Up to day 61 ± 3
AEs of special interests include allergic and anaphylactic reactions, injection site reactions, infections, increased blood lipid levels, increased liver enzyme levels, drug-induced liver injury, neutropenia
Percentage of volunteers (%), who developed binding antibodies to RPH-104
时间窗: Up to day 61 ± 3
Percentage of volunteers (%), who developed binding antibodies to RPH-104
Percentage of volunteers (%), who developed neutralizing antibodies to RPH-104
时间窗: Up to day 61 ± 3
Percentage of volunteers (%), who developed neutralizing antibodies to RPH-104
次要结局
- The area under the plasma drug concentration-time curve (AUC) of RPH-104 from the moment of administration to the last time point of sampling(Up to day 50 ± 1)
- The time to reach the maximum concentration of RPH-104 after a single injection(Up to day 50 ± 1)
- Apparent total clearance of RPH-104 after a single administration(Up to day 50 ± 1)
- The half-life of RPH-104 after a single administration(Up to day 50 ± 1)
- The apparent volume of distribution of RPH-104 after a single administration(Up to day 50 ± 1)
- The elimination constant of RPH-104 after a single administration(Up to day 50 ± 1)